Inhalation apparatus

ABSTRACT

An inhaler is instantly activated upon its removal from a cover or cover unit, and by rotating a cartridge component of the inhaler with respect to a mouthpiece portion, so as to create a flow pathway for ambient air and particles. The cartridge component includes a chamber, whose contents typically include dry powders or the like. Upon creation of the flow pathway, the contents of the chamber are instantly accessible for immediate inhalation by a user through the mouthpiece portion.

This applications claims priority to U.S. Provisional Patent ApplicationNo. 60/366,302 filed Mar. 20, 2002.

TECHNICAL FIELD

The present invention is directed to inhalers, and in particular to drypowder inhalers.

BACKGROUND

Inhalers or inhalation devices that deliver their content in the formsof liquid mists and powder in aerosol forms, are in common use today.However, these inhalers typically employed propellants, whoseeffectiveness is pressure, and thus, altitude and atmosphericallydependent. Additionally, propellants such as chlorofluorocarbonpropellants are banned by treaties, as they are harmful to theenvironment.

As a result, dry powder inhalers or inhalation devices were developed.However, these dry powder inhalers were of limited use, especially whendelivery of medication to the deep lung was desired.

These dry powder inhalers exhibited drawbacks in that their designresulted in particles moving too fast or agglomerating. When particlestraveled too fast, they typically struck the back of the throat, wherethey were swallowed, without ever reaching the lungs. Similarly,particles that agglomerated were too heavy, and typically fell out ofthe inhaled breath stream in the mouth or oral cavity, where they wereswallowed without ever reaching the lungs. Accordingly, the powder, ifany, that reached the lungs was typically in amounts ineffective forproper treatment.

Moreover, these conventional inhalers are relatively large. As a resultof this large size, their portability, in pockets and other compartmentsis limited, and to a greater extent, the space required for their use islarge. For example, the space required for use of these conventionalinhalers would make them difficult, if not impossible to use under a gasmask or the like, as the airspace therein is extremely limited. Coupledwith the amount of space taken up in pockets, first aid kits, etc., manyof these conventional inhalers are not suited for battlefield and otheremergency uses.

SUMMARY

The apparatus, components and methods disclosed herein improve on thecontemporary art by providing a dry powder inhaler whose contents canreach the lungs in amounts effective for treatment of variousconditions. The apparatus disclosed herein includes an inhaler (inhalerportion) that utilizes the user's breath to pass the dry powder from thebody of the device to the lungs of the user, eliminating the need forpropellants. Accordingly, the inhaler disclosed herein can be usedregardless of altitude and atmospheric conditions.

The inhaler disclosed herein is of a configuration, that when the user'sbreath reaches a sufficient predetermined flow rate, the dry powdercontained therein will deagglomerate. These deagglomerated dry powderparticles are then entrained in the inhaled breath stream, allowing forthe contents of the inhaler to reach the lungs in effective amounts.

The inhaler is small and compact. This small size enables use in smallspaces. For example, the inhaler can be placed under, or inserted into,a gas mask or other protection device, to utilize the closed airspacetherein, without disrupting its function. The inhaler can also be forsingle or one-time uses and can be disposable.

The inhaler is instantly activated, upon its removal from a cover orcover unit. The inhaler detaches from the cover by simply pulling it ina direction away from the cover or by rotation, if a high helix threadengagement is present on the cover and inhaler. By rotating a cartridgecomponent of the inhaler, where inhaler medication is stored in achamber, a channel is opened from this chamber to the ambientenvironment. In addition, the storage chamber is opened to themouthpiece, providing immediate access to the chamber contents forimmediate inhalation.

The inhaler is sanitary and its contents are protected until use, as themouthpiece and opening to the ambient environment are under a cover,that engages the body of the inhaler in a locking arrangement until useis desired. Each inhaler can be individually covered, or the individualcovers can be attached so as to be a single unit with formed of multiplecovers with corresponding inhalers.

BRIEF DESCRIPTION OF THE DRAWINGS

Attention is now directed to the drawing figures, where like referencenumerals or characters indicate corresponding or like components. In thedrawings:

FIG. 1 is an isometric view of an embodiment of the apparatus disclosedherein as a single unit;

FIG. 2 is an exploded view of the device of FIG. 1;

FIG. 3A is an isometric view of the mouthpiece of FIG. 2;

FIG. 3B is a front view of the mouthpiece of FIG. 2;

FIGS. 3C and 3D are side views of the mouthpiece of FIG. 2;

FIG. 3E is a rear view of the mouthpiece of FIG. 2;

FIG. 4 is a cross sectional view of the apparatus of FIG. 1 showing itin a closed position;

FIG. 5A is a view of the mouthpiece of FIG. 3D, taken along line 5A—5A;

FIGS. 5B, 5C, 5D are cross sectional views of FIG. 5A, taken along lines5B—5B, 5C—5C and 5D—5D, respectively;

FIG. 6A is a front view of the cartridge of FIG. 2;

FIG. 6B is a view of the cartridge of FIG. 6A taken along line 6B—6B;

FIG. 6C is an exploded view of the cartridge of FIG. 6A;

FIG. 7A is a front view of the apparatus of FIG. 1 with the coverrepositioned on the inhaler portion;

FIG. 7B is a cross-sectional view of the apparatus of FIG. 7A takenalong line 7B—7B;

FIG. 8 is an isometric view second embodiment of an apparatus disclosedherein; and

FIG. 9 is an isometric view of the embodiment of FIG. 8, showing removalof an inhaler portion.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 show an apparatus 20 formed from an inhaler portion(inhaler) 22 and a cover 24. The inhaler portion 22 includes amouthpiece 26, formed of a tube section 28 and a body section 30, and acartridge 32. The mouthpiece 26 includes an interior bore 40 (FIGS. 4and 5A) for receiving the cartridge 32 in a frictional and rotatableengagement, allowing for rotation of the cartridge 32 with respect tothe mouthpiece 26, and vice versa (in accordance with double headedarrow 41). This engagement is maintained by correspondingly positionedriblets 44 (FIGS. 4 and 5A), 45 on the mouthpiece 26 and cartridge 32,that engage each other. Both the mouthpiece 26 and cartridge 32 includeridged collar sections 48, 49 to facilitate gripping by the user, inorder to rotate the cartridge 32 in the mouthpiece 26.

The cover 24 typically attaches to the inhaler portion 22 at the shank52 of the mouthpiece 26. This shank 52 is typically of a diameter justslightly less than the corresponding inner diameter of the cover 24(between inner surfaces 53 of the cover 24). The shank 52 also includesat least one recess 54, for engaging a correspondingly shapedprotrusion(s) 57, typically extending continuously around the innersurface 53 (FIG. 4) of the cover 24. The dimensioning of the shank 52and cover 24, coupled with the corresponding recess 54 and protrusion(s)57, allows the cover 24 to be retained on the mouthpiece 26 in africtional engagement, whereby removal of the cover 24 on the mouthpiece26 requires minimal force. The cover 24 may include cylindrical fingergrip grooves 58 to assist the user in gripping the cover 24 when use ofthe inhaler portion 22 is desired.

The cover 24 and mouthpiece 26 are typically designed, wherereattachment of the cover 24 to the mouthpiece 26 is not possible, aseither the recess 54 or protrusion(s) 57 are damaged during cover 24separation, whereby they are no longer functional for maintaining a theaforementioned engagement. Alternately, the cover 24 and mouthpiece 26could include portions of thread like structures, at least one of whichis stripped upon separation of the inhaler portion 22 from the cover 24,or either of the cover 24 or the mouthpiece 26 includes one-wayratchet-like structures that damage upon the aforementioned separation.This ensures that the inhaler portion 22 will be a single-use one timedevice. Testing the apparatus 20 to make sure that it has not been used,accordingly, involves simply, turning the apparatus 20 upside down, withthe cover 24 facing the ground. If the cover 24 falls off easily, thisis a relatively certain indication that the inhaler portion 22 has beenused.

Turning also to FIGS. 3A-3E and 4 (the apparatus 20 is shown in theclosed or stowed position in FIG. 4), port 60, extends through the shank52. The port 60 includes an inlet opening 62 (through which ambient airenters the inhaler portion 22), over which the cover 24 extends. Thisallows the inhaler portion 22 to be separated from the cover by simplypopping/pulling it off, or, alternately by twisting or rotating it off(in the direction of double headed arrow 63), if a mechanical threadsystem (for example, a high-helix thread engagement) is employed in theinhaler portion 22 and the cover 24.

The cover 24 extends over and the inlet opening 62 and port 60, so as toengage the shank 52 beyond the inlet opening 62, such that the port 60and inlet opening are under cover and not exposed to the ambientenvironment until use (i.e., separation of the inhaler portion 22 fromthe covet 24) is desired. Since under cover, the chance of dustparticles or other particulates that could get into the port 60 and clogit is minimized. The port 60 is, for example, rectangular in crosssection, with other cross-sectional shapes, such as round, alsosuitable. The pert 60 terminates in an inner opening 64, correspondingin shape and dimensions with the opening 122 (FIG. 6B) in the cartridge32.

The mouthpiece 26, in its tube section 28 includes the shank 52, with adischarge tube 70 for particles (from the chamber 110, detailed below),that extends therethrough. As shown in FIG. 5A, the tube 70 includes anopening 72, typically a rounded or circular opening at its inner end 73.Moving outward, the tube 70 has a constant diameter portion 74, followedby a tapered portion 76, and a straight portion 78, terminating in anopening 80, at the outer end 81, through which particles leave theinhaler portion 22 and enter into the oral cavity of a user. These threeportions 74, 76 and 78, couple to deagglomerate residual particleaggregations within the particle flow and control the velocity at whichthe particles are discharged into the oral cavity. Additionally, thelengths of each portion 74, 76 and 78 are optimized so as not to giverise to flow separation (backwards flow that creates vortices oreddies).

The constant diameter portion 74 is of a constant diameter and of alength sufficient for providing the particles with a straight conduitentrance for particle/gas acceleration and the development of ahigh-shear flow field. This portion is typically oval or rounded incross section, as shown in FIG. 5B. This geometry allows for theobliteration of most of the residual agglomerated particles.

The tapered portion 76 is tapered outward (toward outer opening 80),typically at included angles of approximately 3 to 7 degrees, and forexample approximately 4 degrees to achieve, for example, a 2:1 aspectratio. At this aspect ratio, there can be transitioning of the velocityof the particle stream traveling in this tube 70. This tapered portion76, for example, originates with an oval cross-section (FIG. 5B) andtapers outward to a bean or kidney shaped cross section, as shown inFIG. 5C.

The straight portion 78 is of constant dimensions. This allows for thecollimation and velocity control of the particle stream leaving the tube70. This portion 78 is typically in a bean or kidney shape in crosssection, as shown in FIG. 5D, similar to that of the opening 80.However, other shapes are also sufficient, provided they allow forcontrol of the velocity of the particle stream.

A bulb 86 on the outside of the tube section 28, typically a raised ovalor other rounded shape, functions as a tongue depressor, as well as themouthpiece discharge tube locator. Specifically, as shown in detail inFIGS. 3C-3E, 4 and 7B, this shape and dimensioning for the bulb 86 keepsthe tongue down, so as not to block particulate flow in the mouth (oralcavity). The shank 52, in particular where it is of greater diameterthan the tube 70, serves as a stop surface for abutment of the lips of auser, allowing the lips to form a seal around the tube section 28 atthis point for suction, to enhance inhalation. Alternately, there can bea protrusion on the tube section 28, on the side opposite the bulb 86(i.e., tongue depressor), that serves as a stop surface for the lips,allowing the lips to form a seal around the tube section 28 at thispoint for suction, to enhance inhalation.

The interior bore 40 of the mouthpiece 26 is correspondingly shaped withrespect to the shape of the head portion 102 (FIGS. 6A-6C) of thecartridge 32. This bore 40 includes an indented slot 90 (FIGS. 4 and 7B)that allows a correspondingly dimensioned key 154 from the cartridge 32to be detained therein, while typically allowing for rotations of thecartridge 32 in the mouthpiece 26 up to 90 degrees, in order that theinhaler portion 22 be moved from a closed or stowed position (shown inFIG. 4), to an open or inhale position (shown in FIGS. 7A and 7B), forinhalation and transport of particles to the lungs. Detents (not shown),typically positioned 90 degrees from each other, extend into the surface94 of the inner bore 40. These detents are cooperatingly configured toengage berms 150 on the cartridge 32, upon the cartridge 32 beingrotated into the open position (detailed below). These detents typicallyinclude radial or rounded edges, allowing for movement of the cartridge32 with respect to the mouthpiece 26 (and vice versa), between the openand closed positions. Alternately, these detents, if provided withsquare or sharp edges, will be one way, and thus, not allowing formovement back to the closed position (FIG. 4) from the open position(FIG. 7B), whereby the apparatus 20 is a single or one-time useapparatus.

FIGS. 6A-6C show the cartridge 32 in detail. The cartridge 32 istypically formed from a head portion 102 and a tail portion 104, thatcan be in a snap-together frictional assembly, welded together or joinedtogether by other conventional fastening techniques and/or mechanisms.The head 102 and tail 104 portions when joined together house a chamber110 in their combined interior.

An inlet conduit 112, for intake air extends into the chamber 110, inthe head portion 102. This inlet conduit 112 is formed of a feed channel114, correspondingly shaped with respect to the port 60, for alignmentwhen the inhaler portion 22 is in the open position, and a columniationtube 116, that extends from the feed channel 114 (through opening 117 a)into the chamber 110 (through opening 117 b).

An exit tube 118 for particles extends from the chamber 110 (via opening119) to the outer surface 120 of the cartridge 32. This exit tube 118terminates in an opening 122 dimensioned to correspond with the opening72 in the mouthpiece 26 for particle flow therethrough, when thecartridge 32 and mouthpiece 26 are aligned when the inhaler portion 22is in the open position (FIG. 7B).

Within the chamber 110, are ridges 130 a, 130 b, typically rounded inshape. In the tail portion 104, the ridges 130 b extend to form acentral protrusion 132. This protrusion 132 is typically cone shaped,and coupled with the ridges 130 a, 130 b, creates vortices for theparticles (represented by arrows 134) from the airflow through thecolumniation tube 116 (represented by arrows 136). By creating vortices,the particles deagglomerate and are suspended in a concentration of theuniform dry powder aerosol. This effectively maximizes emptying of thechamber 110 and allows particles to be entrained in the breath stream.

Within this chamber 110, inhalant, typically in a dry powder form, isheld. This inhalant can be, for example, Technosphere™ encapsulatedbioactive molecule(s) (Pharmaceutical Discovery Corporation, Elmsford,N.Y. 10523), as described in commonly owned U.S. Provisional PatentApplication No. 60/349,628, entitled: COMPOSITIONS FOR TREATMENT ORPREVENTION OF BIOTERRORISM, the disclosure of which is incorporated byreference herein, or Atropine, antibiotics, such as penicillin,doxycycline, Ciprofloxacin and fluoroquinolones, encapsulated inTechnospheres™, these Technospheres™ and methods for their manufacturedisclosed in U.S. Pat. Nos. 5,352,461, 5,503,852 and 6,071,497, allthree of these U.S. patents incorporated by reference herein.

The head portion 102 is typically formed of a cylindrical portion 140, aconical portion 142 (for example, at approximately a 60-70 degreeincluded angle), and a disc portion 144, over the conical portion 142.Riblets 45 typically extend around the cylindrical portion 140 so as toengage corresponding riblets 44 of the mouthpiece 26, and maintain thefrictional and rotating engagement of the cartridge 32 and mouthpiece 26as detailed above. The conical portion 142 includes an opening 146 forthe feed channel 114, that is typically rectangular to attain optimalflow control, as well as the opening 122 for the exit tube 118.

Berms 150, protrude a slight distance from the surface 151 of theconical portion 142. By extending this slight distance, coupled with thematerial of the cartridge, and thus the berm 150, the berms 150 behavein a spring like manner. The berms 150 are typically of square or sharpedges 152, but could also be radial or rounded at their edges. The berms150 are correspondingly dimensioned for the openings 64, 72 of themouthpiece 26, in which they seat when the apparatus 20 is in the closedposition. (The openings 64, 72 typically include radial or rounded edgesto allow rotation of the cartridge 32 in the mouthpiece 26 from theclosed to the open position). The berms 150 ultimately rest in thedetents (as detailed above),with the spring like behavior of the berms150 providing tactile sensitivity that the cartridge 32 and mouthpiece26 are no longer engaged in the closed initial position and the openposition has been reached. These berms 150 are typically positioned 180degrees from each other (although other positionings are also possible),this 180 degrees corresponding to the positions of the openings 64, 72of the mouthpiece and the respective detents on the mouthpiece 26.

A key 154 extends from the disc portion 144. The key 154 is typically ina crescent shape, and fits within the slot 90 (FIGS. 4 and 7B) in themouthpiece 28, the slot 90 serving as a boundary for the key 154, andaccordingly, having sufficient space to limit rotation of the cartridge32 with respect to the mouthpiece 26 (and vice versa) to for example 90degrees (in order that the rotation be between open and closedpositions).

The tail portion 104 includes the ridged collar section 49, as detailedabove. Additionally, there are threads 158 or ring detents at the end ofthe tail portion 104, that can engage corresponding threads 159 or bermson the cover 24, to keep the cover on the inhaler portion 22.Alternately, this section of the tail potion 104 and correspondingportion of the cover 24 can be made to permanently lock up once joinedtogether, thus promoting one-time use for the apparatus 20, as shown inFIGS. 7A and 7B. However, this attachment of the cover 24 to the tailportion 104 is optional, as normal operation of the inhaler portion 22does not require the cover 24 to be attached to the tail portion 104.

All of the aforementioned components, the cover 24 mouthpiece 26 andcartridge 28, and all structures thereon and/or therein are typicallymade of plastics, polymers or the like, with one such plastic beingacetal plastic, for example DELRIN® 500 and “Antistatic” CELCON®plastics. While these plastics are listed, multiple other plastics,polymers and other materials are also suitable for the componentsmentioned herein. These plastics, polymers and other materials can beselected for example, based on the composition that will be in thechamber 110, environmental and storage factors, and the like. Thesecomponents are typically formed by techniques such as molding and forexample, injection molding.

Turning specifically to FIGS. 7A and 7B, there is detailed the inhalerportion 22 in an open position, ready for use (inhalation of thecontents of the chamber 110). As shown here, the feed channel 114 andexit tube 118 are positioned in the cartridge 32, that having beenrotated, are respectively aligned with the inlet port 60 and thedischarge tube 70. This alignment in the open position, creates a flowpathway for inhalation, from inlet opening 62 (for intake of ambientair), through to the chamber 110, where a particle stream is created,and through the discharge tube 70 of the mouthpiece 26, where theparticle stream in inhaled for ultimate delivery to the lungs, includingthe deep lungs. The inlet port. 60, coupled with the feed channel 114,and the exit tube 118, are typically angled at an angle Θ with respectto the each other of approximately 0 to 180 degrees, and for example,approximately 45 degrees, to avoid large backpressures, that inhibitairflow along the flow pathway.

FIGS. 8 and 9 show a multiple unit system 200. Here, single inhalerportions 222, similar in all aspects to inhaler portions 22 (detailedabove), are in covers 224, similar to covers 24 (detailed above), thatare joined as a single unit. The covers 224 include weakened portions227 and openings 229 between them, allowing for easy separation intoindividual units 20′.

While preferred embodiments of an apparatus, components and methods,have been described above, the description of the apparatus, componentsand methods above is exemplary only. Those skilled in the art willrecognize, or be able to ascertain using no more than routineexperimentation, many equivalents to the specific embodiments of theinvention described herein. Such equivalents are intended to beencompassed by the following claims.

1. A single dosage inhalation apparatus comprising: a mouthpiece, themouthpiece including a central bore having at least one open end and atube for carrying particles to the oral cavity of a user; a cartridgeincluding at least one portion for receipt in the bore in a rotatableengagement, and a chamber for storing an inhalable substance; themouthpiece and the cartridge rotatable with respect to each other, froma first position, where the chamber is closed to an ambient environmentand the mouthpiece tube, to a second position, where a flow pathway fromthe ambient environment to the tube of the mouthpiece through thechamber, has been opened; the mouthpiece and the cartridge includingcooperatingly configured structures to retain the second position oncethe second position has been reached.
 2. The apparatus of claim 1,additionally comprising a cover, the cover adapted for covering themouthpiece.
 3. The apparatus of claim 2, wherein the cover and thecartridge include cooperatingly configured structures for retaining thecover in an engagement with the cartridge, once the cover has beenplaced on the cartridge.
 4. An inhalation method, comprising: providinga single dosage inhalation apparatus comprising: a mouthpiece, themouthpiece including a central bore having at least one open end and atube for carrying particles to the oral cavity of a user; a cartridgeincluding at least one portion for receipt in the bore in a rotatableengagement, and a chamber for storing an inhalable substance; themouthpiece and the cartridge rotatable with respect to each other, froma first position, where the chamber is closed to an ambient environmentand the mouthpiece tube, to a second position, where a flow pathway fromthe ambient environment to the tube of the mouthpiece through thechamber, has been opened; the mouthpiece and the cartridge includingcooperatingly configured structures to retain the second position oncethe second position has been reached; providing an inhalable substancein the chamber; and rotating the cartridge with respect to themouthpiece from the first position to the second position to open theflow pathway.
 5. The method of claim 4, additionally comprising, lockingthe cartridge with respect to the mouthpiece in the second position.